FDA Product Code PEW: Implantable Transprostatic Tissue Retractor System
The Treatment Of Symptoms Due To Urinary Outflow Obstruction Secondary To Benign Prostatic Hyperplasia (bph) In Men Age 50 And Above.
Leading manufacturers include Neotract, Inc..
11
Total
10
Cleared
62d
Avg days
2013
Since
Declining activity -
0 submissions in the last 2 years
vs 1 in the prior period
FDA 510(k) Cleared Implantable Transprostatic Tissue Retractor System Devices (Product Code PEW)
11 devices
About Product Code PEW - Regulatory Context
510(k) Submission Activity
11 total 510(k) submissions under product code PEW since 2013, with 10 receiving FDA clearance (average review time: 62 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.
PEW devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →